BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Files An 8-K Other Events

Item8.01.

On June23, 2017, BioDelivery Sciences International, Inc. (the
Company) issued a press release announcing the regulatory
approval of its product BELBUCA (buprenorphine) buccal film
(CIII)in Canada. A copy of the press release is attached as
Exhibit 99.1 hereto.

Cautionary Note Regarding Forward-Looking
Statements

This Current Report on Form 8-K, the press release included
herein, and any statements of representatives and partners of
BioDelivery Sciences International, Inc. (the Company) related
thereto contain, or may contain, among other things, certain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements involve significant risks and uncertainties. Such
statements may include, without limitation, statements with
respect to the Companys plans, objectives, projections,
expectations and intentions and other statements identified by
words such as projects, may, will, could, would, should,
believes, expects, anticipates, estimates, intends, plans,
potential or similar expressions. These statements are based upon
the current beliefs and expectations of the Companys management
and are subject to significant risks and uncertainties, including
those detailed in the Companys filings with the Securities and
Exchange Commission. Actual results (including, without
limitation, the results of the Companys commercialization and
efforts in Canada for BELBUCA described in the attached press
release) may differ significantly from those set forth in the
forward-looking statements. These forward-looking statements
involve certain risks and uncertainties that are subject to
change based on various factors (many of which are beyond the
Companys control). The Company undertakes no obligation to
publicly update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by applicable law.

BIODELIVERY SCIENCES INTERNATIONAL INC Exhibit
EX-99.1 2 d395238dex991.htm PRESS RELEASE Press Release Exhibit 99.1 BioDelivery Sciences Announces Health Canada Approval of BELBUCA® RALEIGH,…
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About BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company. The Company develops and commercializes, either on its own or in partnerships with third parties, applications of approved therapeutics to address unmet medical needs using drug delivery technologies. The Company develops pharmaceutical products aimed principally in the areas of pain management and addiction. The Company’s products utilize the BioErodible MucoAdhesive (BEMA) drug delivery technology, a small, erodible polymer film for application to the buccal mucosa (the lining inside the cheek). The Company’s United Sates Food and Drug Administration (FDA) approved product, ONSOLIS (fentanyl buccal soluble film), as well as its approved products BUNAVAIL (buprenorphine and naloxone buccal film) buccal film and BELBUCA (buprenorphine) buccal film, utilize BEMA technology.